FDA.reportPublic FDA data

RenovaRP

Primary DI
00893029002731
Brand
RenovaRP
Company
GI Supply, Inc.
Model
GIS-35
Catalog number
GIS-35
Device description
The RenovaRP® Centesis Pump is intended to be used in conjunction with the RenovaRP Tube Set and the RenovaRP Fluid Drainage Bags to remove ascitic fluid from the abdominal cavity for paracentesis, and remove pleural effusion from the thoracic cavity for thoracentesis. The RenovaRP Centesis Pump is intended to be used by medically trained healthcare professionals knowledgeable about paracentesis and thoracentesis.
Published
2023-12-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTAPump, Portable, Aspiration (Manual Or Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTAPump, Portable, Aspiration (Manual Or Powered)General, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221042000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221042000Renova RP Centesis PumpGi Supply, Inc.2023-04-19BTA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00893029002731PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00893029002731008930290027318930290027310893029002731

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction pumpAn electrically-powered device, which may include noninvasive accessories, intended to generate negative pressure for aspiration of body cavities/wounds during a variety of surgical procedures (e.g., general surgery, liposuction, and laparoscopy), typically to facilitate observation; it may also be intended for airway/oral cavity clearance. It is not intended for vascular/thrombectomy use and is not dedicated to thoracic drainage or dental applications; it is not designed for surgical irrigation. The device may incorporate a pressure gauge/controls, and may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-451-5797customer_service@gi-supply.com

Regulatory Flags#

DUNS number
160990313
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00893029002595MoonPants SMGIS-7-SMGIS-7-SM2021-07-20
00893029002601MoonPants MLGIS-7-MLGIS-7ML2021-07-20
00893029002618MoonPants XLGIS-7-XLGIS-7-XL2021-07-20
00893029002625MoonPants LongGIS-13GIS-132021-07-20
00893029002632SportShorts XSSL-9XSSL-9XS2021-07-20
00893029002649SportShorts SMSL-9SMSL-9SM2021-07-20
00893029002656SportShorts MLSL-9MLSL-9ML2021-07-20
00893029002663SportShorts XLSL-9XLSL-9XL2021-07-20
00893029002243EverLiftGIS-59GIS-592021-02-18
00893029002229EverLiftGIS-55GIS-552021-02-18
00893029002236RenovaRPGIS-31GIS-312021-07-08
00893029002175RenovaRPGIS-32GIS-322021-07-06
00893029002168RenovaRPGIS-30GIS-302022-08-10
00893029002151RenovaRPGIS-29GIS-292021-07-07
00893029002076RenovaRPGIS-27GIS-272016-09-24
10893029002165RenovaRP Tube SetGIS-30GIS-302022-08-10
10893029002592MoonPants SMGIS-7-SMGIS-7-SM2021-07-20
10893029002608MoonPants MLGIS-7-MLGIS-7ML2021-07-20
10893029002615MoonPants XLGIS-7-XLGIS-7-XL2021-07-20
10893029002622MoonPants LongGIS-13GIS-132021-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970462546832Suction PumpShenzhen HugeMed Medical Technical Development Co., Ltd.BTA2026-06-04
00860014862731HEYVALUEOak Tech LLCBTA2026-03-27
00860014862748GROWNSYOak Tech LLCBTA2026-03-27
10845854041413APEXConmed CorporationBTA2026-03-23
10845854080153CONMEDConmed CorporationBTA2026-03-23
00810149098246R&D Batteries, Inc.R & D Batteries, Inc.BTA2026-02-12
00810149098222R&D Batteries, Inc.R & D Batteries, Inc.BTA2026-01-20
00860014862700GROWNSYOak Tech LLCBTA2026-01-10
00860014862717GROWNSYOak Tech LLCBTA2026-01-10
00860014862724GROWNSYOak Tech LLCBTA2026-01-10
06973222511606Electric Nasal AspiratorShenzhen Desida Technology Co., Ltd.BTA2025-12-31
00810149098178R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-10-27
00860014577550HEYVALUEOak Tech LLCBTA2025-10-13
00860014577567HEYVALUEOak Tech LLCBTA2025-10-13
00860014577574HEYVALUEOak Tech LLCBTA2025-10-13
00860014577581HEYVALUEOak Tech LLCBTA2025-10-13
00860014577505GROWNSYOak Tech LLCBTA2025-08-26
00860014577512GROWNSYOak Tech LLCBTA2025-08-26
00860014577529GROWNSYOak Tech LLCBTA2025-08-26
06953775661706BBLOVEAlicn Medical Shenzhen, Inc.BTA2025-08-04
07640108052506Endoskopiepumpe Master distributed by KARL STORZ UP033C, 115V, mit FussschalterArdo medical AGBTA2025-07-16
07640108053374Endoskopiepumpe Senator distributed by KARL STORZ UP030C, 115VArdo medical AGBTA2025-07-16
07640108055293Endoskopiepumpe Master distributed by KARL STORZ UP034C, 115VArdo medical AGBTA2025-07-16
00810149097997R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-06-23
00810149097973R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-06-18
00810149097980R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-06-18
06975740361558MomcozyShenzhen Root Innovation Technology Co., Ltd.BTA2025-05-20
06978331170218BASENDongguan Yiyingmei Technology Co., Ltd.BTA2025-03-31
06978331170232BASENDongguan Yiyingmei Technology Co., Ltd.BTA2025-03-31
06978331170249BASENDongguan Yiyingmei Technology Co., Ltd.BTA2025-03-31